Cellcept

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CellCept

INDICATIONS

Renal, Cardiac, and Hepatic
Transplant

CellCept is indicated for the
prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac
or hepatic transplants. CellCept should be used concomitantly with cyclosporine
and corticosteroids.

CellCept Intravenous is an
alternative dosage form to CellCept capsules, tablets and oral suspension.
CellCept Intravenous should be administered within 24 hours following
transplantation. CellCept Intravenous can be administered for up to 14 days;
patients should be switched to oral CellCept as soon as they can tolerate oral
medication.

DOSAGE AND ADMINISTRATION

Renal Transplantation

Adults

A dose of 1 g administered orally or intravenously (over
NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in
renal transplant patients. Although a dose of 1.5 g administered twice daily
(daily dose of 3 g) was used in clinical trials and was shown to be safe and
effective, no efficacy advantage could be established for renal transplant
patients. Patients receiving 2 g/day of CellCept demonstrated an overall better
safety profile than did patients receiving 3 g/day of CellCept.

Pediatrics (3 months to 18 years of age)

The recommended dose of CellCept oral suspension is 600
mg/m² administered twice daily (up to a maximum daily dose of 2 g/10
mL oral suspension). Patients with a body surface area of 1.25 m² to
1.5 m² may be dosed with CellCept capsules at a dose of 750 mg twice
daily (1.5 g daily dose). Patients with a body surface area > 1.5 m² may
be dosed with CellCept capsules or tablets at a dose of 1 g twice daily (2 g
daily dose).

Cardiac Transplantation

Adults

A dose of 1.5 g bid administered intravenously (over NO
LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use
in adult cardiac transplant patients.

Hepatic Transplantation

Adults

A dose of 1 g bid administered intravenously (over NO
LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use
in adult hepatic transplant patients.

CellCept Capsules, Tablets, and Oral Suspension

The initial oral dose of CellCept should be given as soon
as possible following renal, cardiac or hepatic transplantation. Food had no
effect on MPA AUC, but has been shown to decrease MPA Cmax by 40%. Therefore,
it is recommended that CellCept be administered on an empty stomach. However,
in stable renal transplant patients, CellCept may be administered with food if
necessary.

Patients should be instructed to take a missed dose as
soon as they remember, except if it is near the next scheduled dose, and then
continue to take CellCept at the usual times.

Note

If required, CellCept Oral Suspension can be administered
via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior
diameter).

Patients With Hepatic Impairment

No dose adjustments are recommended for renal patients
with severe hepatic parenchymal disease. However, it is not known whether dose
adjustments are needed for hepatic disease with other etiologies (see CLINICAL
PHARMACOLOGY: Pharmacokinetics).

No data are available for cardiac transplant patients
with severe hepatic parenchymal disease.

Preparation of Oral Suspension

It is recommended that CellCept Oral Suspension be
constituted by the pharmacist prior to dispensing to the patient.

CellCept Oral Suspension should not be mixed with any
other medication.

Mycophenolate mofetil has demonstrated teratogenic
effects in rats and rabbits. There are no adequate and well-controlled studies
in pregnant women (see WARNINGS, PRECAUTIONS, ADVERSE
REACTIONS, and HANDLING AND DISPOSAL). Care should be taken to avoid
inhalation or direct contact with skin or mucous membranes of the dry powder or
the constituted suspension. If such contact occurs, wash thoroughly with soap
and water; rinse eyes with water.

Tap the closed bottle several times to loosen the powder.

Measure 94 mL of water in a graduated cylinder.

Add approximately half the total amount of water for
constitution to the bottle and shake the closed bottle well for about 1 minute.

Add the remainder of water and shake the closed bottle
well for about 1 minute.

Remove the child-resistant cap and push bottle adapter
into neck of bottle.

Close bottle with child-resistant cap tightly. This will
assure the proper seating of the bottle adapter in the bottle and
child-resistant status of the cap.

Dispense with patient instruction sheet and oral
dispensers. It is recommended to write the date of expiration of the
constituted suspension on the bottle label. (The shelf-life of the constituted
suspension is 60 days.)

After constitution the oral suspension contains 200 mg/mL
mycophenolate mofetil. Store constituted suspension at 25°C (77°F); excursions
permitted to 15° to 30°C (59° to 86°F). Storage in a refrigerator at 2° to 8°C
(36° to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days
after constitution.

CellCept Intravenous

Adults

CellCept Intravenous is an alternative dosage form to
CellCept capsules, tablets and oral suspension recommended for patients unable
to take oral CellCept. CellCept Intravenous should be administered within 24
hours following transplantation. CellCept Intravenous can be administered for
up to 14 days; patients should be switched to oral CellCept as soon as they can
tolerate oral medication.

CellCept Intravenous must be reconstituted and diluted to
a concentration of 6 mg/mL using 5% Dextrose Injection USP. CellCept
Intravenous is incompatible with other intravenous infusion solutions.
Following reconstitution, CellCept Intravenous must be administered by slow
intravenous infusion over a period of NO LESS THAN 2 HOURS by either peripheral
or central vein.

CAUTION: CELLCEPT INTRAVENOUS SOLUTION SHOULD NEVER BE
ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION (see WARNINGS).

Preparation of Infusion Solution (6 mg/mL)

Caution should be exercised in the handling and
preparation of solutions of CellCept Intravenous. Avoid direct contact of the
prepared solution of CellCept Intravenous with skin or mucous membranes. If
such contact occurs, wash thoroughly with soap and water; rinse eyes with plain
water (see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and HANDLING
AND DISPOSAL).

CellCept Intravenous does not contain an antibacterial
preservative; therefore, reconstitution and dilution of the product must be
performed under aseptic conditions. Additionally, this product is sealed under
vacuum and should retain a vacuum throughout its shelf life. If a lack of
vacuum in the vial is noted while adding diluent, the vial should not be used.

CellCept Intravenous infusion solution must be prepared
in two steps: the first step is a reconstitution step with 5% Dextrose
Injection USP, and the second step is a dilution step with 5% Dextrose
Injection USP. A detailed description of the preparation is given below:

Step 1

Two (2) vials of CellCept Intravenous are used for
preparing each 1 g dose, whereas three (3) vials are needed for each 1.5 g
dose. Reconstitute the contents of each vial by injecting 14 mL of 5% Dextrose
Injection USP.

Gently shake the vial to dissolve the drug.

Inspect the resulting slightly yellow solution for
particulate matter and discoloration prior to further dilution. Discard the
vials if particulate matter or discoloration is observed.

Step 2

To prepare a 1 g dose, further dilute the contents of the
two reconstituted vials (approx. 2 x 15 mL) into 140 mL of 5% Dextrose Injection
USP. To prepare a 1.5 g dose, further dilute the contents of the three
reconstituted vials (approx. 3 x 15 mL) into 210 mL of 5% Dextrose Injection
USP. The final concentration of both solutions is 6 mg mycophenolate mofetil
per mL.

Inspect the infusion solution for particulate matter or
discoloration. Discard the infusion solution if particulate matter or
discoloration is observed.

If the infusion solution is not prepared immediately
prior to administration, the commencement of administration of the infusion
solution should be within 4 hours from reconstitution and dilution of the drug
product. Keep solutions at 25°C (77°F); excursions permitted to 15° to 30°C
(59° to 86°F).

CellCept Intravenous should not be mixed or administered
concurrently via the same infusion catheter with other intravenous drugs or
infusion admixtures.

No data are available for cardiac or hepatic transplant
patients with severe chronic renal impairment. CellCept may be used for cardiac
or hepatic transplant patients with severe chronic renal impairment if the
potential benefits outweigh the potential risks.

Handling And Disposal

Mycophenolate mofetil has demonstrated teratogenic
effects in rats and rabbits (see Pregnancy and WARNINGS: Embryofetal
Toxicity). CellCept tablets should not be crushed and CellCept capsules
should not be opened or crushed. Avoid inhalation or direct contact with skin
or mucous membranes of the powder contained in CellCept capsules and CellCept
Oral Suspension (before or after constitution). If such contact occurs, wash
thoroughly with soap and water; rinse eyes with plain water. Should a spill
occur, wipe up using paper towels wetted with water to remove spilled powder or
suspension. Caution should be exercised in the handling and preparation of
solutions of CellCept Intravenous. Avoid direct contact of the prepared
solution of CellCept Intravenous with skin or mucous membranes. If such contact
occurs, wash thoroughly with soap and water; rinse eyes with plain water.

HOW SUPPLIED

CellCept (mycophenolate mofetil capsules) 250 mg

Blue-brown, two-piece hard gelatin capsules, printed in
black with “CellCept 250” on the blue cap and “Roche” on the brown body.
Supplied in the following presentations:

NDC Number

Size

NDC 0004-0259-01

Bottle of 100

NDC 0004-0259-05

Package containing 12 bottles of 120

NDC 0004-0259-43

Bottle of 500

Storage

Store at 25°C (77°F);
excursions permitted to 15° to 30°C (59° to 86°F).

CellCept (mycophenolate
mofetil tablets) 500 mg

Lavender-colored,
caplet-shaped, film-coated tablets printed in black with “CellCept 500” on one
side and “Roche” on the other. Supplied in the following presentations:

NDC Number

Size

NDC 0004-0260-01

Bottle of 100

NDC 0004-0260-43

Bottle of 500

Storage and Dispensing
Information

Store at 25°C (77°F);
excursions permitted to 15° to 30°C (59° to 86°F). Dispense in light-resistant
containers, such as the manufacturer's original containers.

CellCept Oral Suspension
(mycophenolate mofetil for oral suspension)

Supplied as a white to
off-white powder blend for constitution to a white to off-white mixed-fruit
flavor suspension. Supplied in the following presentation:

NDC Number

Size

NDC 0004-0261-29

225 mL bottle with bottle adapter and 2 oral dispensers

Storage

Store dry powder at 25°C
(77°F); excursions permitted to 15° to 30°C (59° to 86°F). Store constituted
suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)
for up to 60 days. Storage in a refrigerator at 2° to 8°C (36° to 46°F) is
acceptable. Do not freeze.